Back to Intermediate Medical Writing: Pharmaceuticals and Biologics
3.00 RAC

Intermediate Medical Writing: Pharmaceuticals and Biologics

This course provides an overview of the Common Technical Document (CTD), and covers region-specific considerations for clinical sections of the New Drug Application (NDA), Biologics License Application (BLA) and Marketing Authorisation Application (MAA).


Credits:
3.00 RAC

  • List Price: $495.00
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Regulatory and medical writing is an integral part of the product development and approval process and plays a crucial role in assuring that submissions for new products are well organized, accurate and reviewer-friendly.

This course will provide an overview of some of the more complex documents...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design